Parenteral Manual

Nivolumab

Disclaimer: Official controlled document is the CHEO online copy. It is the responsibility of user to ensure that any paper copy version is the same as the online version before use.

Alternate Name(s): 
Opdivo(R)
Classification: 
Anti-PD- 1 monoclonal antibody; immune checkpoint inhibitor
Original Date: 
July 2019
Revised Date: 
November 2019
Indications: 
  • Renal cell carcinoma
  • Other neoplasms, such as colorectal cancer, melanoma, Hodgkin lymphoma, etc
Reconstitution and Stability: 
  • Supplied as 10 mg/mL vials (100 mg & 40 mg). Vials must be refrigerated and protected from light. Do not freeze or shake vials.
  • May be infused undiluted (10 mg/mL) or diluted with NS or D5W
  • When dosed based on weight (ie mg/kg), nivolumab injection can be infused undiluted, or diluted to a concentration as low as 0.35 mg/mL.
  • When dose is fixed (ie 240 mg), nivolumab injection can be infused undiluted or diluted so as not to exceed a total infusion volume of 120 mL.
  • Avoid vigorous mixing or shaking during drug preparation and handling.
  • Undiluted and diluted solutions of Nivolumab are stable 24 hrs refrigerated and protected from light. Single-use vials with no preservative must be discarded 8 hrs after initial entry.
  • Visually inspect drug solution for particulate matter and discoloration prior to administration. Discard if solution is cloudy, if there is pronounced discoloration (solution may have a pale-yellow colour), or if there is foreign particulate matter other than a few translucent to white, amorphous particles. Do not shake.

 

Compatibility: 

- Solutions compatible: NS or D5W

- Incompatible: do not administer other medications through the same IV line

Administration: 

(For approved routes of administration by nursing personnel, refer to Policy for the Administration of Intravenous Medications.)

SC NO
IM

NO

IV Push NO
IV Intermittent Infusion

YES

Usual dilution: may be undiluted, or diluted with NS or D5W to a concentration as low as 0.35 mg/mL. Do not exceed a total infusion volume of 120 mL.

Infuse with a sterile 0.2 - 1.2 micron low-protein binding in-line filter.

Infusion time: give 1st dose over 60 min; if well tolerated, subsequent doses may be given over 30 min.

Flush IV line with NS or D5W at the end of the infusion.

IV Continous Infusion NO

 

Dosage: 

(For neonatal dosages, refer to Neonatal IV Drug Manual.)

  • < 18 years old: 3 mg/kg/dose IV q2weeks (max 240 mg/dose)
  • > 18 years old: 240 mg/dose IV q2weeks

Alternate dosing:

  • 6 mg/kg/dose (max 480 mg/dose) IV q4weeks
Potential hazards of parenteral administration: 
  • Common (> 20%): fatigue
  • Occasional (< 20%): infusion reaction (may include fever, chills, shakes, itching, rash, hyper/hypotension, difficulty breathing during and immediately after Nivolumab administration), anemia, neutropenia, thrombocytopenia, adrenal insufficiency, hyper/hypothyroidism, uveitis, abdominal pain, colitis, diarrhea, dry mouth, nausea, pancreatitis, increased ALT/AST, increased bilirubin, increased creatinine, arthralgia, anorexia, pleural effusion
  • Rare (< 3%): severe allergic reaction, cytokine release syndrome, blurred vision, colonic perforation, mucositis, myositis, rhabdomyolysis, encephalopathy, nervous system disorders, acute kidney injury, autoimmune disorders

For any infusion toxicities, refer to protocol for detailed information on management

Notes: 
  • Anaphylactic precautions at bedside.
  • Vital signs,including BP: immediately prior to infusion, q15min during 1st hr, q30min during 2nd hr and hourly during 3rd hr and until completion of the infusion. Also monitor 30 and 60 min post infusion.
References: 
  • Children's Oncology Group protocol AREN1721; Optiva product monograph accessed 7May2019

 

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